膀胱灌注辣椒辣素类似物治疗特发性膀胱过度活动症随机对照临床研究

Intravesical instillation resiniferatoxin for the treatment of patients with idiopathic overactive bladder:a randomized,placebo controlled clinical trial

目的探讨膀胱灌注辣椒辣素类似物(RTX)治疗特发性膀胱过度活动症(IOAB)的临床效果。方法IOAB患者26例随机分为试验A组和对照B组。A组14例,用100 nmol/L RTX 100 ml灌注膀胱保留30 min后排空。B组12例,用1∶5 000呋喃西林(安慰剂)替代RTX,方法同A组。观察A,B两组用药前、用药后1个月、用药后3个月的临床症状(每日排尿次数、尿急程度)和尿动力学参数(FDV、MCBC、Qmax)。结果治疗前与治疗后1个月、3个月的临床症状和尿动力学参数比较,A组差异有显著意义(P<0.01),B组差异无显著意义(P>0.05)。14/26例(54%)有轻度尿道刺激症状或膀胱区不适,均可耐受。结论RTX单剂量膀胱灌注能安全有效地改善IOAB临床症状和尿动力学指标。

Objective To evaluated the clinical outcomes of intravesical instillation resiniferatoxin（RTX） for the treatment of patients with idiopathic overactive bladder（IOAB）. Methods 26 cases with IOAB were randomly divided into test（A, 14 cases） and control（B, 12 cases） groups. The patients in group A were treated by intravesical instillation with 40ml of 0.5 96 idocain retained within the bladder for 3 minutes at first and with 100ml of 100nmol/L RTX retained within the bladder for 30 minutes late. The patients in group B were treated by the same method, however,the furacilin solution（placebo） at a dilution 1：5000 was used instead of 100nmol/L RTX. The efficacy（daily voiding frequency,urgent uresis,FDV, MCBC, Qmax） of the 2 groups were evaluated before, 1 month and 3 months after treatment. Results The pre-treatment comparion with prost-treatmen at 1 month and 3 months of A group was significant（P 〈 0.01 ）, and B group was not significant（ P 〉 0.05 ）. 14 patients（54 96 ） had slightly stimulating symptom in the urethra or bladder, and were otherwise generally well tolerated. Conclusion Single administration of RTX is safe and effective in patients with IOAB.